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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drug eluting permanent left ventricular (lv) pacemaker electrode
Definition Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Product CodeOJX
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
1 1 9 41 63 47 41 16 11 27 8

Device Problems
Dislodged or dislocated 2321
Failure to capture 1442
No code available 1183
High impedance 893
No Known Device Problem 592
High capture threshold 585
Difficult to position 505
No Information 499
Fracture 461
Patient-device incompatibility 334
Pocket stimulation 315
Capturing issue 245
High sensing threshold 154
Deployment issue 147
Material integrity issue 130
Positioning Issue 128
Device sensing issue 122
Difficult to insert 110
Failure to pace or properly pace 102
Low impedance 101
Break 97
Oversensing 92
Impedance issue 82
Device remains activated 79
Difficult to remove 70
Device operates differently than expected 61
Device contamination with blood or blood product 45
Intermittent capture 41
Connection issue 38
Size incorrect for patient 37
Failure to sense 30
Mechanical issue 29
Use of Device Issue 29
Device damaged prior to use 26
Unstable capture threshold 24
Migration of device or device component 24
Other (for use when an appropriate device code cannot be identified) 23
Dislodged 22
Failure to advance 18
Device expiration issue 17
Defective item 16
Degraded 14
Hole in material 13
Artifact 13
Normal 13
Installation-related problem 13
Device Contamination with biological material 11
Device handling issue 11
Retraction problem 11
Difficult to deploy 11
Failure to deploy 11
Loss of threshold 10
Cut in material 9
Electrical issue 9
Inappropriate shock 8
Kinked 8
Loose or intermittent connection 8
Explanted 7
Disinfection or Sterilization Issue at User Location 7
Ambient noise issue 7
Undersensing 7
No pacing 7
Difficult to advance 7
Human-Device Interface Issue 7
Premature discharge of battery 6
Accessory incompatible 6
Shelf life exceeded 6
Material separation 5
Stretched 5
Component(s), broken 5
Device or device component damaged by another device 5
Programming issue 5
Device inoperable 5
Malposition of device 5
Communication or transmission issue 3
Structural problem 3
Unstable 3
Obstruction within device 3
Material perforation 3
Reset issue 3
Output issue 3
Device-device incompatibility 3
Material deformation 3
Detachment of device component 3
Device alarm system issue 3
Bent 3
Collapse 3
Electro-magnetic interference (EMI) 3
Sensing intermittently 3
Device remains implanted 3
Lead(s), fracture of 3
Performance 2
Difficult to Program or Calibrate 2
Material puncture 2
Failure to shock or properly shock 2
Fluid leak 2
Electronic property issue 2
Foreign material present in device 2
Detachment of device or device component 2
Fitting problem 2
Total Device Problems 11613

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